Another Alzheimer's Drug Just Passed a Crucial Milestone

Last year, Eisai and Biogen’s drug Leqembi gained approval from the Food and Drug Administration for use in treating Alzheimer’s disease. The FDA noted that it was the second drug in a new category of medications taking a different approach to treating Alzheimer’s than its predecessors by “[targeting] the fundamental pathophysiology of the disease.” Now, another drug designed to address the same condition has also crossed an FDA milestone, this one from pharmaceutical company Eli Lilly.

Writing at the Associated Press, Matthew Perrone revealed that Eli Lilly’s drug, donanemab, has been endorsed by the FDA’s advisory panel. The agency will decide whether to approve or reject it later this year.

There were concerns over side effects from donanemab, which led to some brain swelling and bleeding in some patients in the drug’s clinical trials, but the panel’s vote was unanimous in favor of approving it, as they decided the benefits outweigh the risks. As Perrone pointed out, these side effects are a result of the drug’s amyloid-targeting properties. Amyloid plaques play a crucial role in Alzheimer’s effect on the human brain.

According to The New York Times, Eli Lilly suggested that donanemab could be paused after amyloid levels in the brain fell below a certain threshold. “Once the target is cleared from the brain, continued dosing of donanemab is likely not beneficial and only adds to treatment burden and potential risks,” a company statement said.

FDA Advisory Committee Indicates Support for Alzheimer’s Drug Leqembi

This follows an FDA ruling from earlier this year

The Times also pointed out that one of the panelists expressed concern over this proposal. “[T]here will always be a concern in the back of their head: Is it coming back? Am I getting worse?” said panelist Sarah Dolan.

Much like Leqembi, donanemab is designed for patients with an early stage of Alzheimer’s; it can slow someone’s neurological decline, but it can’t stop it outright. But for patients and their loved ones, slowing the disease’s progression may be achievement enough.